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Trial record 4 of 27 for:    papilledema
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Determination of Normal Measures of Optic Nerve Sheath Diameter in Children

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ClinicalTrials.gov Identifier: NCT03178760
Recruitment Status : Recruiting
First Posted : June 7, 2017
Last Update Posted : July 16, 2020
Sponsor:
Information provided by (Responsible Party):
Ozlem Tolu Kendir, Cukurova University

Study Description
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Brief Summary:
The purpose of this study is to measurement of optic nerve sheath diameter in children without intracranial pressure increase and determine the average optic nerve sheath diameters for healthy children.

Condition or disease Intervention/treatment
Optic Papilla Edema Diagnostic Test: Ultrasonic Measurement will be taken from optic nerve sheat diameter and compared-classified.

Detailed Description:

The purpose of this study is to measurement of optic nerve sheath diameter in children without intracranial pressure increase and determine the average optic nerve sheath diameters for healthy children. For that, between 4 and 18 years old children will be selected. After taking of measurements, following parameters will be taken into account and measurements will be classified with those parameters .

  1. Age
  2. Gender
  3. Length (cm)
  4. Weight (kg)
  5. Waist Circumference (cm)
  6. Body Mass Index
Study Design
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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Determination of Normal Measures of Optic Nerve Sheath Diameter in Children
Actual Study Start Date : June 15, 2020
Estimated Primary Completion Date : January 15, 2021
Estimated Study Completion Date : February 15, 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • Diagnostic Test: Ultrasonic Measurement will be taken from optic nerve sheat diameter and compared-classified.

    Ultrasonic Measurement will be taken from optic nerve sheat diameter and compared-classified. Classifications will be done for;

    1. Age
    2. Gender
    3. Weight
    4. Length
    5. Waist Circumference
    6. Body mass index

Outcome Measures
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Primary Outcome Measures :
  1. Measurement of optic nerve sheath diameter [ Time Frame: 1-3 minute ]
    mm


Eligibility Criteria
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Ages Eligible for Study:   4 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Measurements will be classified with gender.
Sampling Method:   Non-Probability Sample
Study Population
all patients without cerebral edema applied the emergency care unit.
Criteria

Inclusion Criteria:

• Children without cerebral edema.

Exclusion Criteria:

• Children with cerebral edema.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03178760


Locations
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Turkey
Akdeniz University Recruiting
Antalya, Turkey
Contact: Ozlem T Kendir, Fellow    +905053049809    otolu80@yahoo.com   
Sponsors and Collaborators
Cukurova University
More Information
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Responsible Party: Ozlem Tolu Kendir, Fellow, Cukurova University
ClinicalTrials.gov Identifier: NCT03178760    
Other Study ID Numbers: AU-70904504/393-19.06.2020
First Posted: June 7, 2017    Key Record Dates
Last Update Posted: July 16, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ozlem Tolu Kendir, Cukurova University:
Optic nerve sheath diameter
average optic nerve sheath diameter for healthy children
Additional relevant MeSH terms:
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Papilledema
Optic Nerve Diseases
Cranial Nerve Diseases
Nervous System Diseases
Eye Diseases